MANAGEMENT OF RIATA LEADS AT TIME OF GENERATOR CHANGE
The St Jude Medical Riata ICD lead, is currently the subject of a hazard alert. This is related to failure of the silicone insulation.
This is a guide to the management of the lead at time of generator change
Device: St Jude Ellipse VR and DR Implantable Cardioverter Defibrillators Model Nos.: CD1277 ( ‐ 36 and ‐ 36Q), CD1377 ( ‐ 36, ‐ 36Q, ‐ 36C and ‐ 36QC), CD2277 ( ‐ 36 and ‐ 36Q), CD2377 ( ‐ 36, ‐ 36Q, ‐ 36C and ‐ 36QC) Advisory Grade TGA: Class I Hazard Alert (Implanted devices) and Recall (Devices on shelves)
ANZDACC Advisory Grade: Semi Urgent
Device: St. Jude Medical ICDs and CRT-Ds programmed with Merlin Programmer Software Version 17.2.2 rev. 0 Inappropriate Programmer Setting of Return to Sinus Detection Criteria in SJM ICDs and CRT-Ds Programmed to a Single VF Detection Zone
Advisory Grade: Hazard Alert (Implanted Devices)
Australian and New Zealand Cardiac Device Advisory and Complications Committee (ANZCDACC)
Device: Reply and Esprit DR (Dual Chamber) and SR (Single Chamber) Pacemakers
Advisory Grade: Hazard Alert (Implanted Devices)
